Fibrin Glue in Inguinal Lymphadenectomy
Primary Purpose
Seroma
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Application of fibrin glue sealant
Sponsored by
About this trial
This is an interventional treatment trial for Seroma focused on measuring Fibrin glue, Seroma, Inguinal lymphadenectomy, Wound complication
Eligibility Criteria
Inclusion Criteria:
• Patients scheduled to perform ILND for various causes
Exclusion Criteria:
- BMI more than 35,
- Uncompensated diabetes
- Advanced liver disease
- Previous history of surgery and/or irradiation to the inguinal region
- Preoperative chemotherapy
- Significant coagulation disorders
- Platelet counts <100,000/mL.
- Use of systemic steroids or anticoagulants.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Fibrin glue
Control
Arm Description
A fibrin glue was applied to the lymphadenectomy bed before wound closure and insertion of a drain.
Lymphadenctomy wound was closed after insertion of a drain,
Outcomes
Primary Outcome Measures
Number of Participants With Seroma Formation
Collection of serous fluid under the wound flaps. According to the Common Terminology Criteria for Adverse Events (CTCAE) 4.0, Grade 2 and Grade 3 were considered.
Grade 2 indicates it is symptomatic; simple aspiration indicated. Grade 3 indicates it is symptomatic, elective radiologic or operative intervention indicated
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04666051
Brief Title
Fibrin Glue in Inguinal Lymphadenectomy
Official Title
Is There a Role for Fibrin Glue (Sealant) in Seroma Reduction After Inguinal Lymphadenectomy?
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
May 2015 (Actual)
Primary Completion Date
October 2020 (Actual)
Study Completion Date
October 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Menoufia University
4. Oversight
5. Study Description
Brief Summary
Seroma is one of the most common encountered morbidities after inguinal lymph node dissection (ILND). It can cause not only much nuisance to both patients and doctors but also its presence can lead to many complications. This study aimed at evaluation of the role and effect of using fibrin glue on seroma reduction in patients undergoing ILND. Thirty-two patient have undergone ILND for various causes. The patients were randomized into two groups; 16 ILND in each. In one group, fibrin glue sealant was applied with a dose of 2ml per 100 cm2 surface area then drain placement was performed. Whereas, in the control group, only drain placement was used. Preoperative, operative and postoperative data were recorded and analyzed.
Detailed Description
Seroma is one of the most frequent complications occurring after ILND as it affects nearly one third of these cases. During the past decades, many actions have been tried in the perioperative care to decrease the incidence of these complications, as employing well vascularized bulky flaps to obliterate the dead space and to protect vessels, great saphenous vein sparing, strict bed rest and fibrin sealant application. Realizing the underlying pathology for seroma formation is the key point in its prevention. Thirty-nine patients scheduled to perform Inguinal lymphadenectomy for various causes have been checked for eligibility to be enrolled in this prospective, randomized study. Thirty-two patients have met the inclusion criteria. Inguinal lymphadenectomy has been performed including scarifying saphenous vein. Sartorius muscle transposition flap was routinely performed for protection of femoral vessels, then an 18 French conventional non-suction tube drain was inserted in all patients. All the previous steps were similar in both groups. At this stage, the wound was closed for the control group, while fibrin glue was prepared to be applied to the fibrin glue group in a dose of 2mL for 100 cm2 surface area. Postoperatively, the daily collected drain fluid was measured till the drain was removed when the daily drainage was less than 30 ml. Then the patients were planned to be followed up postoperatively for at least 4 weeks, to detect the possible clinically encountered complications as seroma, wound infection, or skin flap necrosis.
Patients' demographic data and preexisting co-morbidities were recorded. Operative and pathological data regarding defect size, blood transfusion, primary tumor pathology, and number and status of retrieved lymph nodes were collected. The occurrence of post-operative seroma was the primary outcome. Other non serious adverse effect as hematoma, infection, or skin flap necrosis were recorded and compared between the two groups.
The normality of distribution of variables was verified by Kolmogorov- Smirnov test. Chi-square test (Fisher or Monte Carlo) was used for comparisons between groups for categorical variables. Student t-test was used to compare two groups for normally distributed quantitative variables. For not normally distributed quantitative variables, Mann Whitney test was used to compare between two groups. P value was set to be significant if <0.05.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seroma
Keywords
Fibrin glue, Seroma, Inguinal lymphadenectomy, Wound complication
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fibrin glue
Arm Type
Experimental
Arm Description
A fibrin glue was applied to the lymphadenectomy bed before wound closure and insertion of a drain.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Lymphadenctomy wound was closed after insertion of a drain,
Intervention Type
Biological
Intervention Name(s)
Application of fibrin glue sealant
Primary Outcome Measure Information:
Title
Number of Participants With Seroma Formation
Description
Collection of serous fluid under the wound flaps. According to the Common Terminology Criteria for Adverse Events (CTCAE) 4.0, Grade 2 and Grade 3 were considered.
Grade 2 indicates it is symptomatic; simple aspiration indicated. Grade 3 indicates it is symptomatic, elective radiologic or operative intervention indicated
Time Frame
4 weeks postpertively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
• Patients scheduled to perform ILND for various causes
Exclusion Criteria:
BMI more than 35,
Uncompensated diabetes
Advanced liver disease
Previous history of surgery and/or irradiation to the inguinal region
Preoperative chemotherapy
Significant coagulation disorders
Platelet counts <100,000/mL.
Use of systemic steroids or anticoagulants.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
M. Ashraf Balbaa, M.D.
Organizational Affiliation
Menoufia University
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Study protocol will be available to be shared on request after study publication for 6 months.
IPD Sharing Time Frame
Six months from the time of study publication
IPD Sharing Access Criteria
Contacting the corresponding author
Citations:
PubMed Identifier
22424660
Citation
Buda A, Fruscio R, Pirovano C, Signorelli M, Betti M, Milani R. The use of TachoSil for the prevention of postoperative complications after groin dissection in cases of gynecologic malignancy. Int J Gynaecol Obstet. 2012 Jun;117(3):217-9. doi: 10.1016/j.ijgo.2011.12.021. Epub 2012 Mar 15.
Results Reference
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Fibrin Glue in Inguinal Lymphadenectomy
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